Multitude Therapeutics’ AMT-676 receives Breakthrough Therapy Designation from China’s CDE

CAR-T Digest - August 2020

05 August 2026: Multitude Therapeutics’ AMT-676 receives Breakthrough Therapy Designation from China’s CDE

Multitude Therapeutics’ CDH17-targeted ADC AMT-676 has been granted Breakthrough Therapy Designation by China’s CDE for the treatment of patients with advanced microsatellite-stable/proficient mismatch repair (MSS/pMMR) colorectal cancer who have progressed following two or more prior lines of standard therapy
The designation is supported by phase 1 data from 246 enrolled patients, where AMT-676 achieved a 20% ORR and 91% DCR among efficacy-evaluable CRC patients treated at 7.2–12 mg/kg; in the 8 mg/kg cohort, ORR reached 26%
The program addresses a significant unmet need in advanced CRC after second-line or later standard therapy, where reported ORRs are only 1%–6% and median PFS is 2.0–5.6 months. AMT-676 has so far demonstrated a favorable safety profile, with manageable hematologic and gastrointestinal toxicities
AMT-676 is a potential first-in-class CDH17-directed ADC comprising a high-affinity CDH17 antibody, protease-cleavable linker and exatecan topoisomerase I inhibitor payload. Its payload is a weak substrate for BCRP/P-gp efflux pumps, while the linker-payload combination has demonstrated an enhanced bystander effect in preclinical studies
Strategically, the BTD further validates Multitude Therapeutics’ strategy of developing ADCs against novel targets and strengthens AMT-676’s position as a potential first-in-class CDH17 ADC, with the program currently being evaluated in a phase 1 study across CRC and other advanced solid tumors